YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 339 drug applications between 28 February 2025 and 6 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 76, covering 58 drug names.

2025/02/28 – 2025/03/06

Period
2025/02/28 to 2025/03/06, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
339
Drugs with new generic filings (by drug name, de-duplicated)
58
Accepted this week, now under review
8

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Names with a public page are linked.

New acceptances this week

By application type and drug type

339filings, 76 of them generic

By application type

Application typeFilings
Supplement179
Generic76
New drug54
Import13
Import re-registration11
Unspecified6

By drug type

Drug typeFilings
Chemical drug215
TCM78
Therapeutic biologic42
Prophylactic biologic3
Biologic1

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

58 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Polidocanol Injection5223
2Oxaliplatin Injection314
3Loxoprofen Sodium Oral Solution226
4Mupirocin Ointment2230
5Acetylcysteine Granules214
6Lactulose Oral Solution2134
7Ibrutinib Tablets210
8Levetiracetam Tablets216
9Baricitinib Tablets2132
10Famotidine Injection218

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

191 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Lin Hai Xue Yuan Pharma Co., Ltd. romanized24220
2Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized820
3Bayer AG810
4Shanghai Min Wei Bio Technology Co., Ltd. romanized810
5Guizhou San Ren Tang Pharma Co., Ltd. romanized770
6Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized550
7Merck Sharp & Dohme B.V.530
8Pfizer Inc.530
9Novo Nordisk A/S510
10Nanjing San Die Ji Pharmaceuticals Technology Co., Ltd. romanized510

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

108 this week

AcceptedDrugApplicants
2025/03/06Import · Class 2.2 古塞奇尤单抗注射液 · No verified English nameJXSS2500022 Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.
2025/03/06Import · Class 1 PF-07275315注射液 · No verified English nameJXSL2500035 Pfizer Inc.; Pfizer Investment CO. Ltd.
2025/03/06Import · Class 1 BI 1291583 片 · No verified English nameJXHL2500035 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2025/03/06Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2500941 Hebei Tian Cheng Pharma Co., Ltd. romanized
2025/03/06Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2500940 Beijing SL Pharmaceutical Co., Ltd.
2025/03/06Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2500939 Hui Yu Yuan He (Hainan) Pharma Co., Ltd. romanized; Hubei Jin Yao Pharma Co., Ltd. romanized
2025/03/06Generic · Class 3 Loxoprofen Sodium Oral SolutionCYHS2500933 Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2025/03/06Generic · Class 3 咪达唑仑鼻喷雾剂 · No verified English nameCYHL2500057 Sichuan Pu Rui Te Pharma Co., Ltd. romanized
2025/03/06Generic · Class 3 Irbesartan and Amlodipine TabletsCYHL2500056 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized
2025/03/06New drug · Class 1 注射用维贝柯妥塔单抗 · No verified English nameCXSS2500034 Le Pu Bio Technology Co., Ltd. romanized; Dong Yao Pharma Co., Ltd. romanized
2025/03/06New drug · Class 1 IMM27M注射液 · No verified English nameCXSL2500204 Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2025/03/06New drug · Class 1 TQB2930注射液 · No verified English nameCXSL2500203 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2025/03/06New drug · Class 1 TQB2930注射液 · No verified English nameCXSL2500202 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2025/03/06New drug · Class 1 CM336注射液 · No verified English nameCXSL2500201 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2025/03/06New drug · Class 1.4 ACYW135X群脑膜炎球菌多糖结合疫苗 · No verified English nameCXSL2500200 Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized
2025/03/06New drug · Class 1 丁二酸复瑞替尼胶囊 · No verified English nameCXHS2500021 Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized
2025/03/06New drug · Class 2.2; 2.4 优替德隆胶囊 · No verified English nameCXHL2500251 Chengdu Hua Hao Zhong Tian Pharma Co., Ltd. romanized; Beijing Hua Hao Zhong Tian Biopharmaceuticals Co., Ltd. romanized
2025/03/05Import · Class 1 CagriSema注射液 · No verified English nameJXSL2500034 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd.
2025/03/05Import · Class 1 CagriSema注射液 · No verified English nameJXSL2500033 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2025/03/05Import · Class 1 CagriSema注射液 · No verified English nameJXSL2500032 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2025/03/05Import · Class 1 CagriSema注射液 · No verified English nameJXSL2500031 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2025/03/05Import · Class 1 CagriSema注射液 · No verified English nameJXSL2500030 Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd.
2025/03/05Import · Class 1 PF-06821497片 · No verified English nameJXHL2500034 Pfizer Inc.; Pfizer Investment Co. Ltd.
2025/03/05Import · Class 1 PF-06821497片 · No verified English nameJXHL2500033 Pfizer Inc.; Pfizer Investment Co. Ltd.
2025/03/05Generic · Class 3 Terlipressin Acetate InjectionCYHS2500927 Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2025/03/05Generic · Class 3 Fudosteine oral solutionCYHS2500925 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2025/03/05Generic · Class 3 美洛昔康纳米晶注射液 · No verified English nameCYHS2500924 Yangtze River Pharmaceutical Group Co., Ltd
2025/03/05Generic · Class 3 Loxoprofen Sodium Oral SolutionCYHS2500923 Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized
2025/03/05Generic · Class 3 聚乙二醇3350散 · No verified English nameCYHS2500920 Hefei Sheng Qin Pharmaceuticals Technology Co., Ltd. romanized; Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized
2025/03/05New drug · Class 1 注射用重组人源化抗BCMA/CD3双特异性抗体 · No verified English nameCXSL2500199 Shandong Xin Shi Dai Pharma Co., Ltd. romanized

78 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

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